Our Naperville Printed Circuit Solutions team is looking for a Quality Engineer. The Quality Engineer will work closely with Advanced Quality Planning engineering, Process Engineers and manufacturing team members to create and maintain a quality plan. This person will also manage and mitigate project risk to ensure a flawless product launch. This person will support day to day operations with respect to problem solving, customer concern resolution, and quality system related assignments.

REQUIREMENTS:

• BS Degree in Engineering or other related field
• At least 3 years of Quality Experience in a manufacturing environment
• At least 2+ experience in medical device manufacturing/FDA requirements
• Experience with root cause and corrective action analysis and documentation
• At least 1+ year of knowledge of statistics with Minitab or similar software

WHAT YOU WILL DO IN YOUR ROLE

• Quality Plan Development: Ensure the project quality plan for new products and product modifications are focused on the voice of customer and all project quality deliverables are completed in a timely manner. Understand and apply requirements specific to industries such as medical and automotive.
• Metrology & Qualification: Facilitate the development of measurement plans / methods and lead the disposition of new products at First Off Tool (FOT) and qualification. Assist plant process engineers in design of gages and inspection fixtures, Measurement System Analysis (MSA) studies, capability studies & any necessary statistical analysis with the goal of tool and process qualification. This includes Installation Qualification, Operation Qualification and Performance Qualification (IQOQPQ), equipment validation, and process validation.
• Quality System: Work with all departments to ensure compliance to ISO13485 and FDA 21 CFR820 requirements. Perform internal audits as required.
• Customer Concerns: Ensure documentation relating to customer acceptance of new products and product modifications are completed. Provide corrective action reports to customers.
• Supplier Quality Engineering Functions. Supplier Approval: Review and approve suppliers’ product-specific documentation on new and modified purchased components. Work with suppliers on quality issues to resolution.

FOR THIS ROLE, WE ANTICIPATE PAYING $75,000-$100,000 PER YEAR. THIS ROLE IS ELIGIBLE FOR VARIABLE PAY, ISSUED AS A MONETARY BONUS OR IN ANOTHER FORM.

In order to comply with U.S. export control laws and regulations, this position requires applicants to either provide proof of U.S. citizenship or lawful permanent resident status or be eligible to receive an export authorization (a license) under the International Traffic in Arms Regulations and/or the Export Administration Regulations.